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FDA Drug Application 206111 by BOEHRINGER INGELHEIM

Application Number206111
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/26/2015N43779000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111lbl.pdf 9/2/2015
AP08/26/2015N43780000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s000ltr.pdf 9/2/2015
AP08/26/2015N46723000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206111Orig1s000TOC.cfm 8/4/2016
AP07/8/2016SE846511001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf 7/12/2016
AP07/8/2016SE847139001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s001s006s009lbl.pdf 9/21/2016
AP012/4/2015SLR44665002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s002ltr.pdf 12/7/2015
AP012/4/2015SLR44703002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111s002lbl.pdf 12/8/2015
AP07/8/2016SLR47138006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s001s006s009lbl.pdf 9/21/2016
AP07/8/2016SLR47147006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf 9/22/2016
AP05/6/2016SCM       
AP07/8/2016SLR47137009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s001s006s009lbl.pdf 9/21/2016
AP07/8/2016SLR47146009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf 9/22/2016
AP09/28/2016SCM       




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